Elderly NSCLC/D vs DP (JCOG0207)

Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190476

Enrollment

230

Registered

2005-09-19

Start date

2003-04-30

Completion date

2007-04-30

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell Lung Cancer

Keywords

Elderly, advanced, non-small-cell lung cancer, cisplatin, docetaxel, weekly, combination, chemotherapy, randomized trial

Brief summary

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Detailed description

The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination. Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Interventions

DRUGWeekly docetaxel alone

DRUGWeekly docetaxel + cisplatin combination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Inclusion criteria

1. histologically or cytologically proven non-small-cell lung cancer 2. stage IV, or stage III disease ineligible for definitive radiotherapy 3. 70 years or older 4. ECOG PS 0-1 5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy 6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms 7. No prior surgery within 4 weeks before enrollment 8. No prior radiotherapy for primary tumor 9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment 10. Adequate organ function 11. Signed informed consent

Exclusion criteria

1. Symptomatic brain metastasis 2. Active another neoplasms 3. Severe SVC syndrome 4. Massive pericardial, pleural effusion, or ascites 5. Bone metastasis emergent for palliative radiotherapy or surgery 6. Uncontrollable systemic hypertension 7. Heart failure, Unstable angina, Myocardial infarction within 6 months 8. Uncontrollable diabetes 9. Active infection 10. Interstitial pneumonia/ Pulmonary fibrosis 11. Hypersensitivity for polysorbate 80 12. Systemic administration of corticosteroids

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
Toxicity	—
Progression-free survival	—
Response rate	—
Symptom score	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026